---
title: Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
nct_id: NCT01056328
overall_status: COMPLETED
phase: NA
sponsor: Abbott Medical Devices
study_type: INTERVENTIONAL
primary_condition: Paroxysmal Atrial Fibrillation
countries: United States, Canada, South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01056328.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01056328"
ct_last_update_post_date: 2019-02-26
last_seen_at: "2026-05-12T06:31:27.714Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

**Official Title:** Irrigated Ablation System Evaluation for AF

**NCT ID:** [NCT01056328](https://clinicaltrials.gov/study/NCT01056328)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 324
- **Lead Sponsor:** Abbott Medical Devices
- **Conditions:** Paroxysmal Atrial Fibrillation
- **Start Date:** 2010-02
- **Completion Date:** 2013-01
- **CT.gov Last Update:** 2019-02-26

## Brief Summary

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age 18 years or older
* Signed Patient Informed Consent Form
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements
* Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation\* \[class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation\*, or intolerable side effects due to AAD
* Subjects with symptomatic paroxysmal atrial fibrillation (PAF)\*

  * PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.

Exclusion Criteria:

* Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for AF
* History of any valvular cardiac surgical procedure
* Coronary artery bypass grafting (CABG) procedure within the last six months
* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
* Left atrial thrombus
* History of a documented thromboembolic event within the past one (1) year
* Diagnosed atrial myxoma
* An implanted implantable cardioverter defibrillator (ICD)
* Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
* Acute illness or active systemic infection or sepsis
* Unstable angina
* Myocardial infarction within the previous two months
* Left ventricular ejection fraction (LVEF) \<40% as determined by pre-procedure transthoracic echocardiogram (TTE)
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation (i.e. heparin or warfarin)
* Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
* Life expectancy less than 12 months
* Enrollment in an investigational study evaluating another device or drug
* Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
* An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
* Presence of a condition that precludes vascular access
* Left atrial size ≥ 50 mm as determined by pre-procedure TTE
```

## Arms

- **St. Jude Medical Cardiac Ablation System** (EXPERIMENTAL)
- **FDA approved Open Irrigated Radio Frequency Ablation System** (ACTIVE_COMPARATOR)

## Interventions

- **SJM Irrigated Cardiac Ablation System** (DEVICE) — Irrigated ablation catheter
- **FDA approved Open Irrigated RF Ablation System** (DEVICE) — Irrigated ablation catheter

## Primary Outcomes

- **Confirmation of Entrance Block in the Pulmonary Veins** _(time frame: 20 minutes after initial isolation)_
- **Incidence of Adverse Events Included in the Pre-specified Composite** _(time frame: 7 days)_ — Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
- **Incidence of Adverse Events Included in the Pre-specified Composite.** _(time frame: 12 months)_

## Secondary Outcomes

- **Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period** _(time frame: 12 months)_
- **Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs** _(time frame: 12 months)_

## Locations (30)

- University of Alabama at Birmingham, Birmingham, Alabama, United States
- Arizona Arrhythmia Consultants/Scottsdale Healthcare, Scottsdale, Arizona, United States
- Good Samaritan Hospital, Los Angeles, California, United States
- University of Californai, San Diego Medical Center, San Diego, California, United States
- Colorado Cardiac Alliance, Colorado Springs, Colorado, United States
- Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center, Jacksonville, Florida, United States
- Tampa General Hospital, Tampa, Florida, United States
- Emory University Hospital, Midtown, Emory, Georgia, United States
- University of Kansas Hospital, Kansas City, Kansas, United States
- Washington Adventist Hospital, Takoma Park, Maryland, United States
- Spectrum Health, Grand Rapids, Michigan, United States
- MAHI, Saint Luke's Hospital, Kansas City, Missouri, United States
- NYU Langone Medical Center, New York, New York, United States
- Mount Sinai Hospital, New York, New York, United States
- University of Rochester, Rochester, New York, United States
- University Hospitals Case Medical Center, Cleveland, Ohio, United States
- Cleveland Clinic, Cleveland, Ohio, United States
- The Ohio State University Medical Center, Columbus, Ohio, United States
- Doylestown Hospital, Doylestown, Pennsylvania, United States
- Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Centennial Medical Center, Nashville, Tennessee, United States
- Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, United States
- Baylor Heart & Vascular Hospital, Dallas, Texas, United States
- The Methodist Hospital Research Institute, Houston, Texas, United States
- Intermountain Medical Center, Salt Lake City, Utah, United States
- University of Virginia Health System, Charlottesville, Virginia, United States
- Inova Fairfax Hospital / Inova Heart and Vascular Institute, Falls Church, Virginia, United States
- Sunybrook Health Sciences Centre, Toronto, Ontario, Canada
- Severance Hospital, Seoul, South Korea
- Korea University Anam Hospital, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of alabama at birmingham|birmingham|alabama|united states` — added _(2026-05-12)_
- `locations.arizona arrhythmia consultants/scottsdale healthcare|scottsdale|arizona|united states` — added _(2026-05-12)_
- `locations.good samaritan hospital|los angeles|california|united states` — added _(2026-05-12)_
- `locations.university of californai, san diego medical center|san diego|california|united states` — added _(2026-05-12)_
- `locations.colorado cardiac alliance|colorado springs|colorado|united states` — added _(2026-05-12)_
- `locations.diagnostic cardiology associates, p.a.; st. vincents medical center|jacksonville|florida|united states` — added _(2026-05-12)_
- `locations.tampa general hospital|tampa|florida|united states` — added _(2026-05-12)_
- `locations.emory university hospital, midtown|emory|georgia|united states` — added _(2026-05-12)_
- `locations.university of kansas hospital|kansas city|kansas|united states` — added _(2026-05-12)_
- `locations.washington adventist hospital|takoma park|maryland|united states` — added _(2026-05-12)_
- `locations.spectrum health|grand rapids|michigan|united states` — added _(2026-05-12)_
- `locations.mahi, saint luke's hospital|kansas city|missouri|united states` — added _(2026-05-12)_
- `locations.nyu langone medical center|new york|new york|united states` — added _(2026-05-12)_
- `locations.mount sinai hospital|new york|new york|united states` — added _(2026-05-12)_
- `locations.university of rochester|rochester|new york|united states` — added _(2026-05-12)_
- `locations.university hospitals case medical center|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.cleveland clinic|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.the ohio state university medical center|columbus|ohio|united states` — added _(2026-05-12)_
- `locations.doylestown hospital|doylestown|pennsylvania|united states` — added _(2026-05-12)_
- `locations.hospital of the university of pennsylvania|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.centennial medical center|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.texas cardiac arrhythmia research foundation|austin|texas|united states` — added _(2026-05-12)_
- `locations.baylor heart & vascular hospital|dallas|texas|united states` — added _(2026-05-12)_
- `locations.the methodist hospital research institute|houston|texas|united states` — added _(2026-05-12)_
- `locations.intermountain medical center|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.university of virginia health system|charlottesville|virginia|united states` — added _(2026-05-12)_
- `locations.inova fairfax hospital / inova heart and vascular institute|falls church|virginia|united states` — added _(2026-05-12)_
- `locations.sunybrook health sciences centre|toronto|ontario|canada` — added _(2026-05-12)_
- `locations.severance hospital|seoul||south korea` — added _(2026-05-12)_
- `locations.korea university anam hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01056328.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01056328*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*